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Drug Facts
Product Repackaged and Distributed
with permission of Pfizer Consumer Healthcare by:
Select Corporation Carrollton, TX 75007
The following Structured Product Label (SPL) was submitted to the FDA by Select Corporation for the product Advil Sinus Congestion And Pain (NDC 52904-782). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, otc - purpose, uses, allergy alert, stomach bleeding warning, heart attack and stroke warning, do not use, ask a doctor before use if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Drug Facts
Product Repackaged and Distributed
with permission of Pfizer Consumer Healthcare by:
Select Corporation Carrollton, TX 75007
| Active ingredients (in each tablet) | Purposes |
|---|---|
| Ibuprofen 200 mg (NSAID) nonsteroidal anti-inflammatory drug | Pain reliever/fever reducer |
| Phenylephrine HCl 10 mg | Nasal decongestant |
Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:
If an allergic reaction occurs, stop use and seek medical help right away.
This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you:
NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed.
If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use ibuprofen during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
acesulfame potassium, artificial flavor, carnauba wax, colloidal silicon dioxide, corn starch, croscarmellose sodium, glycerin, hypromellose, lactic acid, lecithin, maltodextrin, medium-chain triglycerides, microcrystalline cellulose, pharmaceutical ink, polydextrose, polyvinyl alcohol, pregelatinized starch, propyl gallate, sodium lauryl sulfate, stearic acid, sucralose, synthetic iron oxide, talc, titanium dioxide, triacetin, xanthan gum
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